BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVI INFUSION PUMP

    MDR report key: 252011 · Received November 22, 1999

    Report

    Report Number
    252011
    Event Type
    Death
    Date Received
    November 22, 1999
    Date of Event
    November 6, 1999
    Report Date
    November 19, 1999
    Manufacturer
    3M AVI, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSING HUNG 1400CC'S OF HYPERAL TO INFUSE AT 58CC/HR PER AVI INFUSION PUMP. APPROX. TWO HOURS LATER THE PUMP WAS ALARMING AND THE NURSE NOTICED THE BAG WAS ALMOST EMPTY. IV INFUSION RATE ON PUMP WAS NOTED TO BE 588. PUMP WAS PLACED ON STANDBY AND THE RATE RESET TO 58CC/HR AND RESTARTED. THE NURSE NOTED THE PUMP CONVERTED BACK TO A RATE OF 588CC/HR. THE PUMP WAS UNPLUGGED AND REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI INFUSION PUMP IV INFUSION PUMP DUAL CHAMBER FRN 3M AVI, INC. 880 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R